FUJIFILM - Validation Engineer - Thermal validation

Do you want to join an advanced biotech company that develops and manufactures some of the leading biological products on the market today and for the future? Then join FUJIFILM Diosynth Biotechnologies in Hillerød (FDBD), a biotech company that aspires to be the leading CDMO within our areas of expertise.  We are looking for the right Validation Engineer or a candidate with experience as Validation Technician to the Chamber Validation team.

About the Department

The Chamber validation team is a part of the larger Validation department, responsible for equipment qualification and cleaning validation. The department is supporting the existing production facility but is also involved in the large expansion project where we are doubling the production capacity. The department will over the coming year grow in tact with the finalizing the new part of the factory.

About the Team you join and your Role

The Chamber validation team consists of 3-4 people. The chamber validation team is responsible for validating and re-validation of freezers, refrigerators, incubators, and controlled rooms. You will be in contact with many different departments, such as QA, QC laboratories, Engineering, production, and warehouse in the Hillerød Facility. Your daily work will be a combination of setting up probes for temperature logging, data evaluation, preparing validation documentation and planning coming validation activities.

Main responsibilities

• You will be the primary contact person to the chamber team.
• You will be responsible for coordinating and plan project activities and yearly re-validations together the rest of the team.
• Participate in projects as thermal validation subject matter expert.
• Perform validation and re-validation protocols, reports, and the physical testing.
• Data evaluate data and Deviation handling.
• Coordinate with production, QC, warehouse, and engineering in relation to test.
• Represent the area at regulatory and customer inspections.
• Update procedures and instructions.
• Responsible for our temperature loggers and their calibrated status.

Competences and skills

• You hold a bachelor’s or another relevant technical education. Most important is that you have at least 2-3 years of relevant industry experience preferable within temperature mapping and/or validation.
• You are self-starting and have a flexible, dynamic approach to work.
• knowledge with validation, preferable validation of temperature-controlled rooms and equipment.
• Used to write and review validation report/ protocols and perform validation testing.
• Good English skills spoken and written. English is the company language.
• Experience from pharmaceutical production will be preferred.

You bring a friendly, can-do mindset, professionalism, and a good sense of humor.

Your application

Has this sparked your interest? Then we urge you to please upload your CV and cover letter in English as soon as possible as we screen candidates on a continuous basis. The job will be removed when the right candidate has been identified.

In case you have any questions or doubts, then please do not hesitate to reach out to Hanne Toft, Sr. Manager Validation at +45 23712992.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Application via website: https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Validation-Engineer---Chamber-validation_JR1262